Xylitol-based anti-mucosal compositions and related methods and compositions

ABSTRACT

Compositions and methods for alleviating an allergy condition while also reducing a drying effect of an allergy medication or another anti-mucosal composition. In some embodiments, a nasal solution for alleviating an allergy condition may comprise an anti-mucosal composition in an amount effective for treating an allergy condition and at least one of xylitol and xylose in an amount effective for reducing nasal dryness caused by the anti-mucosal composition.

RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §119(e) of U.S.Provisional Patent Application No. 61/651,741 filed May 25, 2012 andtitled “XYLITOL-BASED ANTI-MUCOSAL COMPOSITIONS AND RELATED METHODS ANDCOMPOSITIONS,” which application is incorporated herein by reference inits entirety.

SUMMARY

Disclosed herein are examples of embodiments and implementations ofcompositions and methods for alleviating an allergy condition while alsoreducing a drying effect of an allergy medication or other anti-mucosalcomposition.

In some embodiments, a nasal solution for alleviating an allergycondition may comprise an anti-mucosal composition in an amounteffective for treating an allergy condition and at least one of xylitoland xylose in an amount effective for reducing nasal dryness caused bythe anti-mucosal composition. The anti-mucosal composition may compriseat least one of an antihistamine, a nasal steroid, cromolyn sodium,phenylephrine hydrochloride, oxymetazoline hydrochloride, azelastineHCL, mometasone furoate, and a decongestant. The anti-mucosalcomposition may alternatively comprise a natural antihistamine, such asechinacea, chamomile, and/or basil.

The nasal solution may comprise a nasal spray, and may further comprisea nasal spray bottle configured to deliver the nasal solution.Alternatively, the nasal solution may comprise a nasal dropperconfigured to deliver the nasal solution in a liquid drop form.

In another example of a composition for alleviating an allergycondition, the composition may comprise an anti-mucosal composition inan amount capable of reducing the symptoms of an allergy condition,wherein the anti-mucosal composition comprises a drying agent effectivefor resulting in a drying effect on at least one of a typical user'snose, eyes, mouth, and throat. The composition may further comprise atleast one of a polysaccharide, a monosaccharide, and a sugar alcoholconfigured to counteract the drying effect and in an amount effectivefor reducing the drying effect of the drying agent. The at least one ofa polysaccharide, a monosaccharide, and a sugar alcohol may comprise atleast one of xylitol, erythritol, xylose, mannitol, maltitol, ribitol,arabitol, and ribose.

In some embodiments, the composition may comprise a nasal solution. Insuch embodiments, the nasal solution may comprise a nasal spray, and mayfurther comprise a nasal spray bottle configured to deliver the nasalsolution. In other embodiments, the nasal solution may comprise a gel.

In some implementations of methods for treating an allergy condition andsimultaneously reducing the drying effect of an allergy treatment agent,the method may comprise identifying a subject having an allergycondition and providing a solution. The solution may comprise ananti-mucosal composition comprising an allergy treatment agent in anamount effective for treating the allergy condition and at least one ofxylitol and xylose in an amount effective for reducing the drying effectof the allergy treatment agent. Such methods may further comprisedelivering the solution into at least one of the subject's nose, eyes,mouth, and throat.

In some implementations, the solution may comprise a nasal solution,and, in such implementations, the step of delivering the solution maycomprise delivering the nasal solution into the subject's nose.

The allergy treatment agent may comprise at least one of anantihistamine, a nasal steroid, cromolyn sodium, phenylephrinehydrochloride, oxymetazoline hydrochloride, azelastine HCL, andmometasone furoate. The solution may comprise an aqueous solution or agel. In implementations in which the solution comprises a gel, the stepof delivering the solution may comprise delivering the gel using anadhesion delivery method. The gel may comprise a bio-adhesive agent insome implementations.

BRIEF DESCRIPTION OF THE DRAWINGS

The written disclosure herein describes illustrative embodiments thatare non-limiting and non-exhaustive. Reference is made to certain ofsuch illustrative embodiments that are depicted in the figures, inwhich:

FIG. 1 illustrates intranasal delivery of an anti-mucosal compositionincluding xylitol consistent with embodiments of the present disclosure.

DETAILED DESCRIPTION

Anti-mucosal compositions, including antihistamines, are widely used toalleviate allergy symptoms such as itching and a runny nose.Antihistamines may prevent histamines produced by the body's immuneresponse from attaching to histamine receptors in the nose and/orthroat, thereby reducing allergy systems. Blocking this histamineresponse, however, has certain undesirable side effects. For example,administration of antihistamines and/or other anti-mucosal compositionsmay cause an individual's nasopharynx, nose, and/or throat to becomeuncomfortably dry and such dryness may lead to further conditions and/orcomplications.

For purposes of the disclosure contained herein, an “anti-mucosal”composition includes any composition that decreases the production orpresence of mucous, including but not limited to antihistamines, nasalsteroids, cromolyn sodium, phenylephrine hydrochloride, oxymetazolinehydrochloride, azelastine HCL, mometasone furoate, decongestants, andnatural antihistamines and decongestants, such as echinacea, chamomile,and basil.

Consistent with embodiments disclosed herein, certain polysaccharides,monosaccharides, polysaccharides, or sugar alcohols, such as xylitol,may be administered in conjunction with anti-mucosal compositions toalleviate at least some of the negative side effects of the anti-mucosalcompositions. For example, in certain embodiments, administeringanti-mucosal compositions in conjunction with xylitol may reduce drynessassociated with the use of the anti-mucosal compositions in anindividual's nasopharynx, nose, and/or throat that would normallyotherwise be associated with use of the anti-mucosal composition alone.In some embodiments, polysaccharides, monosaccharides and/or sugaralcohol compositions utilized in the anti-mucosal compositions disclosedherein may be prepared, at least in part, utilizing methods disclosed inU.S. Pat. Nos. 6,054,143 and 6,258,372, both titled “XYLITOL NOSE SPRAY”and U.S. Pat. No. 6,599,883 titled “NASAL DELIVERY OF XYLITOL,” each ofwhich is hereby incorporated by reference in its entirety.

Xylitol in particular has been shown to be very effective inmoisturizing nasal passages and the like. Without being limited bytheory, this is thought to occur because xylitol can create ahyper-osmotic solution that pulls moisture towards it from surroundingtissues without generated mucous. Thus, the combination of xylitol, orother similar compositions disclosed herein, and anti-mucosal agents,results in a decrease in mucous production without the accompanyingdryness that typically accompanies antihistamines and otheranti-mucosals, along with the accompanying anti-bacterial and otherhealth benefits associated with xylitol and other similar agents.

Certain polysaccharides, monosaccharides, or sugar alcohols, includingxylitol, have other beneficial properties aside from reducing dryness inthe nasopharynx, nose, and/or throat. For example, regular consumptionof xylitol has been shown to reduce the incidence of dental caries. Thisbenefit is at least in part attributed to xylitol's ability to inhibitand/or reduce the growth and acid production of Streptococcus mutans, animportant bacterium involved in the pathomechanism of dental caries.Xylitol may similarly inhibit the growth of Streptococcus pneumonia invitro during its logarithmic growth phase. Streptococcus pneumonia isattributed to causing several harmful conditions, including certaintypes of pneumonia, upper respiratory infections, sinus infections, andother infectious diseases, including meningitis, sepsis, and acuteotitis media episodes. Accordingly, administering xylitol in conjunctionwith anti-mucosal compositions may also help prevent and/or alleviatesuch other harmful conditions.

As detailed above, polysaccharides, monosaccharides and/or sugaralcohols utilized in the anti-mucosal compositions disclosed herein mayinclude xylitol. Other exemplary polysaccharides, monosaccharides and/orsugar alcohols suitable for use in the anti-mucosal compositionsdisclosed herein may include, for example, erythritol, xylose, mannitol,maltitol, ribitol, arabitol, and/or ribose. Any other suitablepolysaccharides, monosaccharides, and/or sugar alcohols that, whenadministered, reduce side effects associated with anti-mucosalcompositions may also be utilized in other embodiments.

Anti-mucosal compositions including one or more polysaccharides,monosaccharides, and/or sugar alcohols may be delivered via anintranasal pathway. For example, an anti-mucosal composition includingone or more polysaccharides, monosaccharides, and/or sugar alcohols maybe delivered to an individual's nasopharnyx via a nasal spray. FIG. 1illustrates intranasal delivery of an anti-mucosal composition includingone or more polysaccharides, monosaccharides, and/or sugar alcohols 108consistent with embodiments disclosed herein.

Anatomically, the nasopharynx 100 is a point at which the nasal passages106 merge into one. It is also where the floor of the nose 104 bendsdownward with the superior-posterior surface of the palate. The openingsof the auditory tubes (i.e., eustachian tubes) and the posterior nasalapertures (i.e., choanae) are located within the nasopharynx 100. Theoropharynx 102 is located inferior to the nasopharynx 100 and is behindthe mouth 114. By virtue of the anatomic locations of the eustachiantube openings in the nasopharynx 100, nasal administration of asolution, suspension, gel or powder may result in a more effectiveexposure of the eustachian tube openings versus administration via anoral route. Accordingly, administering anti-mucosal compositionsincluding one or more polysaccharides, monosaccharides and/or sugaralcohols 108 via an intranasal pathway may be more effective than otherroutes of administration (e.g., orally, topically). However, it isanticipated that in other embodiments and implementations, one or moreof the compositions disclosed herein may alternatively be administeredorally by way of drops, a spray, a gel, a solution, or the like.

In certain embodiments, administering anti-mucosal compositionsincluding one or more polysaccharides, monosaccharides, and/or sugaralcohols 108 via an intranasal pathway may be performed utilizing anasal spray bottle 110. The nasal spray bottle 110 may any suitablebottle configured to retain anti-mucosal compositions including one ormore polysaccharides, monosaccharides, and/or sugar alcohols 108 and todistribute (e.g., spray) the anti-mucosal compositions including one ormore polysaccharides, monosaccharaides, and/or sugar alcohols 108 intoan individual's intranasal pathway and/or nasopharynx 100 using a pumpmechanism 112. Alternatively, the composition may be delivered fromother nasal spray bottles by simply squeezing the bottle. In certainembodiments, the anti-mucosal compositions including one or morepolysaccharides, monosaccharides, and/or sugar alcohols 108 may bestored in the nasal spray bottle 110 in liquid or powder form, and maybe distributed into the intranasal pathway and/or nasopharnyx 100 as anaerosol.

In some embodiments, the anti-mucosal compositions including one or morepolysaccharides, monosaccharides, and/or sugar alcohols 108 may beadministered using a bathing delivery method. A bathing delivery methodmay utilize a solution comprising the anti-mucosal compositionsincluding one or more polysaccharides, monosaccharides, and/or sugaralcohols 108 contained within a dilute (e.g., a less viscous, more fluidcomposition) pharmaceutically acceptable carrier suitable for nasaladministration. For example, the anti-mucosal compositions including oneor more polysaccharides, monosaccharides and/or sugar alcohols 108 maybe contained within an aqueous solution including water and/or otherpharmaceutically-acceptable carrier components. In certain embodiments,the composition may comprise approximately 0.1% saturation of a suitableaqueous solution. In certain embodiments, the composition may compriseapproximately 1-15% of a suitable aqueous solution. The compositions mayalso comprise one or more polysaccharides, monosaccharides, and/or sugaralcohols 108, although other aqueous solution compositions are alsocontemplated. Some embodiments may comprise xylitol in an amount ofbetween about 10 g/ml and about 60 g/ml.

The bathing delivery method may directly deliver the compositionincluding one or more polysaccharides, monosaccharides, and/or sugaralcohols 108 to the nasopharynx 100 in conjunction with subsequentbathing of the nasopharyngal area. As discussed above, this may beachieved using a nasal spray bottle 110. However, in alternativeimplementations, the composition may be delivered using alternativedelivery mechanisms, such as droppers, misters, atomizers, brushes,swabs, etc. In some embodiments, utilizing a free-flowing, low viscosityaqueous solution may allow for a rapid and concentrated application ofthe composition.

In further embodiments, the anti-mucosal compositions including one ormore polysaccharides, monosaccharides, and/or sugar alcohols 108 may beadministered using an adhesion delivery method. An adhesion deliverymethod may utilize a more viscous solution, such as a gel, to deliverthe anti-mucosal compositions including one or more polysaccharides,monosaccharides, and/or sugar alcohols 108. In certain embodiments, theviscous solution may include a bio-adhesive agent. An adhesion deliverymethod may rely on the adhesion of a solution containing theanti-mucosal compositions including one or more polysaccharides,monosaccharides, and/or sugar alcohols 108 to the nasal mucous membraneand a slow migration of the solution to the nasopharyngeal area.Utilizing a more viscous solution may provide for a more gradual andsteady application of the composition to desired areas, such as withinthe nasal cavity, and may also increase the duration of the positivebenefits of the composition, such as by decreasing the rate at which thecomposition is removed from the desired areas.

In certain embodiments, a solution including anti-mucosal compositionsand one or more polysaccharides, monosaccharides, and/or sugar alcohols108 may include a buffer, a thickening agent, a bio-adhesive, and/or ahumectant. A pharmaceutically acceptable surfactant and a preservativemay also be included along with one or more excipients suitable for apharmaceutical composition.

In embodiments including a buffer, the buffer may be configured tomaintain a pH level of the solution. Exemplary suitable buffers includeacetate, citrate, and phosphate buffers. The thickening agent mayinclude, for example, one or more of methylcellulose, xanthan gum,carboxyl methylcellulose, polyvinyl alcohol, hydropropyl cellulose,carbomer, starches, chitosans, acrylates, and mixtures therefore. Incertain embodiments, these substances may also act as suitablebio-adhesives. Suitable exemplary humectants include sorbitol, propyleneglycol, glycerol, and/or any combination thereof. Suitable surfactantsmay be anionic, cationic, or nonionic, and may include polyoxyethylenederivatives, fatty acids, and/or partial esters of sorbitol anhydrides.For example, the surfactant may include sodium lauryl sulfate,polysorbate 80, polyoxyl Stearate, polyoxy ethylene 50, fusieates, bilesalts, and octoxynol. However, it should also be understood that manyembodiments of the compositions disclosed herein will not need toinclude a buffer.

It will be understood by those having skill in the art that changes maybe made to the details of the above-described embodiments withoutdeparting from the underlying principles presented herein. For example,the anti-mucosal compositions including one or more polysaccharides,monosaccharides, and/or sugar alcohols 108 disclosed herein may beadministered via liquid drops from a dropper, topically (in some casesusing a cotton swab or the like), orally, via a mister or atomizer,and/or via any other suitable manner of administration. In addition, anysuitable combination of various embodiments, or the features thereof, iscontemplated.

Any methods disclosed herein may comprise one or more steps or actionsfor performing the described method. The method steps and/or actions maybe interchanged with one another. In other words, unless a specificorder of steps or actions is required for proper operation of theembodiment, the order and/or use of specific steps and/or actions may bemodified. It should also be understood that some implementations can bepracticed without some or all of the steps disclosed herein. Inaddition, the steps of a method do not necessarily need to be executedin any specific order, or even sequentially, nor need the steps beexecuted only once, unless otherwise specified.

Throughout this specification, any reference to “one embodiment,” “anembodiment,” or “the embodiment” means that a particular feature,structure, or characteristic described in connection with thatembodiment is included in at least one embodiment. Thus, the quotedphrases, or variations thereof, as recited throughout this specificationare not necessarily all referring to the same embodiment.

Similarly, it should be appreciated that in the above description ofembodiments, various features are sometimes grouped together in a singleembodiment, figure, or description thereof for the purpose ofstreamlining the disclosure. This method of disclosure, however, is notto be interpreted as reflecting an intention that any claim require morefeatures than those expressly recited in that claim. Rather, inventiveaspects lie in a combination of fewer than all features of any singleforegoing disclosed embodiment. It will be apparent to those havingskill in the art that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples set forth herein. The scope of the present invention should,therefore, be determined only by the following claims.

The invention claimed is:
 1. A method for treating an allergy conditionin a human, the method consisting essentially of the steps of:identifying a human having an allergy condition; and administering tothe human having an allergy condition a composition consistingessentially of therapeutically effective amounts of at least one ofxylitol and xylose and at least one of cromolyn sodium, phenylephrinehydrochloride, oxymetazoline hydrochloride, azelastine hydrochloride,and mometasone furoate to treat said allergy in the human having anallergy.
 2. The method of claim 1, wherein the composition is in anaqueous solution.
 3. The method of claim 1, wherein the step ofadministering to the human having an allergy condition is via deliveringthe composition into at least one of the human's nose, eyes, mouth, andthroat.
 4. The method of claim 1, wherein the composition is a nasalsolution.
 5. The method of claim 4, wherein the step of administering tothe human having an allergy condition is via delivering the nasalsolution into the human's nose.
 6. The method of claim 4, wherein thecomposition is a gel.
 7. The method of claim 6, wherein the step ofadministering to the human having an allergy condition via deliveringthe gel using an adhesion delivery method.
 8. The method of claim 1,wherein the step of administering to the human having an allergycondition is via at least one of a nasal spray bottle, a dropper, amister, an atomizer, a brush, and a swab.
 9. The method of claim 8,wherein the step of administering to the human having an allergycondition is via a nasal spray bottle.
 10. The method of claim 8,wherein the composition is a free-flowing, low viscosity aqueoussolution.
 11. The method of claim 1, wherein the at least one of xylitoland xylose is an amount effective for reducing nasal dryness caused bythe at least one of cromolyn sodium, phenylephrine hydrochloride,oxymetazoline hydrochloride, azelastine hydrochloride, and mometasonefuroate.